On April 23, the NMPA website published the "Announcement on Matters Related to Optimizing the Application for Listing and Registration of Drugs Manufactured Outside China for Transferring to Domestic Manufacture That Are Already Marketed in Domestic Markets (No. 49 of 2024)".
It is mentioned that the NMPA will include the scope of priority review and approval for the application for registration of drugs and biological products that have been transferred from original research and development to domestic production. For the transfer of overseas-produced drugs that have been listed in the domestic market to the domestic market, the domestic applicant shall submit the application in accordance with the requirements and procedures for the application for listing and registration of drugs.
If a foreign-produced pharmaceutical product already listed in China is transferred to domestic production, the original registration declaration information of the foreign-produced pharmaceutical product may be submitted, and the relevant research information of the transferred domestic production may be submitted to support the application for registration of the drug on the market. The specific requirements for the declaration information shall be separately formulated and issued by CDE.
